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NCT01534663 · ClinicalTrials.gov registry record · Phase 2
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01534663: Completed Phase 2 study, sponsored by Columbia University.
NCT01534663 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01534663, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.
Primary Outcome
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
Interventions
- DRUG Placebo
- DRUG Glutamine and Fish Oil Supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01534663 record still lists
NCT01534663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01534663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01534663 about?
NCT01534663 is a clinical study titled "Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure". The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation...
What is the current status of trial NCT01534663?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01534663?
The interventions under investigation include: Placebo (DRUG), Glutamine and Fish Oil Supplementation (DRUG).
Who is sponsoring clinical trial NCT01534663?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01534663's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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